About this trial
The purpose of this study is to evaluate the feasibility and effectiveness of a self-guided digital Acceptance and Commitment Therapy (ACT) intervention for adolescents who engage in non-suicidal self-injury (NSSI). The intervention is delivered through a mobile-based program and consists of seven modules focusing on acceptance, cognitive defusion, present-moment awareness, self-as-context, values, and committed action. Adolescents will complete the intervention over a 3-week period and will be randomly assigned to the intervention or control condition. The study will examine whether the digital ACT intervention can reduce NSSI and improve psychological flexibility and other indicators of mental health, including depression, anxiety, hope, and emotion regulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be adolescents aged 10-19 years (Sawyer et al., 2018).
Have engaged in five or more self-injurious behaviors within the past year and meet the DSM-5 diagnostic criteria for Non-Suicidal Self-Injury (NSSI) (American Psychiatric Association, 2013).
Provide assent to participate, with written informed consent obtained from both the adolescent and their legal guardian.
Have access to a smartphone capable of completing the study procedures, including logging into the study mini-program to complete the self-guided intervention and sending and receiving text messages.
Disqualifiers
Have an intellectual disability or other significant cognitive, neurodevelopmental, or visual impairment that may interfere with their ability to complete the study procedures.
Have a severe physical illness.
Be experiencing an acute episode of a severe mental disorder, such as a manic episode of bipolar disorder.
Have experienced suicidal ideation or a suicide attempt within the past month.
Trial design
Parallel
Treatments tested in this trial
ACT-Based Chatbot
BehavioralThe intervention is a fully automated, text-based chatbot delivered via a mobile application or web platform. It is based on the core processes of Acceptance and Commitment Therapy (ACT). Over three weeks, participants will engage with the chatbot for approximately 10 minutes per day, 3 days per week. The chatbot delivers structured modules covering: (1) acceptance and willingness to experience difficult emotions; (2) cognitive defusion techniques; (3) present-moment awareness; (4) self-as-context; (5) values clarification; and (6) committed action. The chatbot includes safety protocols that provide crisis resources and emergency contact information if participants report severe self-harm urges or suicidal ideation. The intervention is designed to be self-guided, with no human therapist involvement, to ensure scalability and accessibility.
Treatment groups
Trial outcomes
Primary outcomes
Severity of non-suicidal self-injury behaviors
The Behavior subscale of the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ) will be used to assess adolescents' non-suicidal self-injury behaviors and functions. The Behavior subscale consists of 12 items, rated on a 5-point Likert scale ranging from 0 (never) to 4 (always).
Secondary outcomes
Depression
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depressive symptoms. The questionnaire consists of nine items, each rated from 0 to 3. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Anxiety
The Generalized Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptoms. The scale consists of seven items rated on a 4-point scale: 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
Other outcomes
Psychological flexibility
The 24-item Multidimensional Psychological Flexibility Inventory (MPFI-24) will be used to measure psychological flexibility. The MPFI-24 assesses two broad domains: psychological flexibility (PF) and psychological inflexibility (PI), comprising 24 items in total. Items are rated on a 6-point scale. PF includes six processes: contact with the present moment, acceptance, cognitive defusion, self-as-context, committed action, and values. PI includes six processes: lack of contact with the present moment, experiential avoidance, cognitive fusion, self-as-content, inaction, and lack of contact with values.
Hope
The Children's Hope Scale (CHS) will be used to assess adolescents' goal-related cognitive tendencies, including agency thinking and pathways thinking. The scale consists of six items across two dimensions. Items are rated on a 6-point Likert scale ranging from 1 (never) to 6 (always), with higher scores indicating higher levels of hope.
Emotion Regulation Strategies
The Regulatory Emotional Self-Efficacy Scale (RES) will be used to assess adolescents' perceived self-efficacy in regulating their emotions. The scale consists of 12 items across three dimensions. Items are rated on a 5-point scale ranging from 1 (strongly inconsistent with me) to 5 (strongly consistent with me).
Functions of Non-Suicidal Self-Injury
The Function subscale of the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ) will be used to assess the functions underlying adolescents' NSSI. The Function subscale consists of 19 items, rated on a 5-point Likert scale ranging from 0 (never) to 4 (always).
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Central China Normal University
Lead sponsor
Wuhan Mental Health Centre
Collaborator
This trial is not recruiting at the moment. You can still explore other options: